Objective: To compare the efficacy of galantamine and donepezil in the treatment of moderate-to-severe AD patients over 1 year.
Design: Galantamine and donepezil are approved therapies available for the treatment of mild-to-moderate AD, and both have demonstrated significant clinical efficacy as well as good levels of safety and tolerability in large clinical trials.
Materials and Methods: In a multicenter trial, patients (N=188) diagnosed with moderate-to-severe AD (NINCDS-ADRDA criteria) received either galantamine 24 mg/day (n=97) or donepezil 10 mg/day (n=91) for 52 weeks in a rater-blinded, randomized, comparative, parallel-group study. Efficacy was compared across multiple domains, eg, the Bristol Activities of Daily Living Scale (BrADL), Mini-Mental State Examination (MMSE) and Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog). The Cognitive Drug Research Assessment Scale (COGDRAS) battery, which includes specific measures of attention, was performed at selected centers. Other outcome measures included the Screen for Caregiver Burden (SCGB), which measured the burden and resource utilization during the study.
Results: Equivalent meaningful benefit was demonstrated for both drugs on the BrADL. Significant advantages were found for galantamine compared with donepezil on cognition at Weeks 13, 26, and 52 as measured by the MMSE. Galantamine-treated patients demonstrated a greater response at week 52 as measured by maintained or improved ADAS-cog/11 (45.2%) and MMSE (55.3%) scores compared with donepezil-treated patients (33.3% and 34.6%, respectively). All 3 attentional tasks of the COGDRAS demonstrated a notable treatment response to galantamine being fast in onset and significant at 6 weeks. Objective and Subjective Burden, as measured by the SCGB, demonstrated short-term significant improvement and long-term maintenance with galantamine compared with donepezil. At the end of the trial, 80.4% patients initially randomized to galantamine remaining on active therapy compared with 78.0% of donepezil-treated patients. Of the 36 patients who experienced severe adverse reactions, 18 (18.6%) were randomized to galantamine and 18 (19.8%) were randomized to donepezil.
Conclusion: This rater-blinded, randomized, comparative study of galantamine and donepezil indicated that moderate-to-severe AD patients exhibited a greater treatment response with galantamine compared with donepezil for 1 year in the areas of cognition (particularly attention) and caregiver burden. Safety and tolerability profiles were similar, suggesting that galantamine provides some distinct long-term treatment benefits in the management of moderate-to-severe AD patients.
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